Sept. 6, 2011 – The FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC) issued three Warning Letters and nine Untitled Letters in the past four months, according to DDMAC officials speaking at an Enforcement Webinar held Aug. 25. The Webinar was part of a DDMAC pilot program to allow stakeholders to better understand and learn from the enforcement actions the agency issues in a recent quarter.
The promotional materials that were the subject of these enforcement actions included one magnet, one detail aid, one booklet, one flyer, two flashcards, and six Web sites (one of which was a YouTube video). Three of these alleged violations came to DDMAC’s attention through complaints under its “Bad Ad” program.
“These DDMAC programs give drug sponsors and their marketing partners clear guidance on the enforcement priorities of the FDA,” said John Kamp, executive director of the Coalition for Healthcare Communication. “DDMAC is responding to complaints elicited through the Bad Ad program. Marketers must pay attention to Internet promotions and detail aids that could violate FDA policies.”
The DDMAC Webinar detailed several specific violations that drew Untitled and Warning Letters in the last few months:
- Omission/minimization of risk
- Unsubstantiated claims (e.g., unsubstantiated superiority claims)
- Broadening of indication
- Overstatement of efficacy
- Omission of material facts
- Promotion of an investigational drug
- Misleading claims (i.e., those related to dosing, compliance)
- Failure to submit under Form 2253
In a Warning Letter issued for promotion of an investigational drug on the company’s Web site, DDMAC explains that it finds the promotion “concerning from a public health perspective” because it suggests that the drug “is safe and effective when the product has not been approved by the FDA and the promotional claims made have not been demonstrated by substantial evidence or substantial clinical experience.”
DDMAC has said it
is holding these “focused Webinars” to “support DDMAC”s mission to protect the public health by assuring prescription drug information is truthful, balanced, and accurately communicated.”
On Sept. 26 and 27, Tom Abrams, head of DDMAC, and representatives of the other marketing enforcement centers at the FDA will be making additional enforcement presentations at the FDLI marketing meeting in Washington, D.C. (link to the FDLI Marketing Conference Agenda). On Tuesday, Sept. 27, Kamp will be moderating a luncheon panel with industry legal experts addressing these issues and the legal ramifications of the IMS Supreme Court decision issued in June.